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Application of Quality Risk Management to Process Validation

Robert Dream, Managing Director, HDR Company LLC

A Holistic Phase Appropriate Strategy for HCP-Limits and HCP Characterization

Dr. Markus Haindl, Global Head Gene Therapy Technical Research & Development, Roche Di...

Strategies for Extractable and Leachable Risk Assessment of Polymeric Single Use Systems U...

Ping Wang, Director, Johnson & Johnson

Use of Non-Contact Raman Spectroscopy to Derive Reaction Kinetics

Richard Hart, Senior Director – Head of Automation and Data Science (Previously Asso...

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JSR Life Sciences


Featured Articles

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

Trends in Single-Use Mixing Technologies and Insight into Pall and Lonza Ibex® Solutions

Volume Reduction and Process Optimization with Cadence Inline Concentrator

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Headline News

Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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Upcoming Webinars

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Past Webinars

High-Resolution Optical and Dielectric Methods Monitoring Cells in Bioprocesses

Presented by Michael Butler, PhD, Professor and Principal Investigator, National Institute for Bioprocessing Research and Training (NIBRT)
19th October 2020


Challenges In Therapeutic Biological Products

Presented by Paolo Grisostomi, Senior Engineer, Materials Science at Biogen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific and Dr. Sona Kovackova, Study Director Small Volume Parenteral applications, Nelson Labs Europe
18th August 2022


Near-infrared spectroscopy for monitoring Maillard reaction and critical process parameters of a C. tetani bioprocess

Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur and Gabriella Gerzon, PhD Candidate, York University, Toronto, Canada and Dean Roberts, Director of Market and Technology Development, Bruker Applied Spectroscopy, North America
16th November 2021


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